MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. RATCHETING HANDLE - PALM; WRENCH (RATCHETING HANDLES)

Catalog Number 07.02105.001

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the ratcheting mechanism on a handle was found to be non-functional during a routine inspection.There were no surgical or patient impacts associated with this event.

Manufacturer Narrative

The returned device was evaluated.The ratcheting mechanism was found to not be functional.It is likely that improper drying of the ratchet resulted in rusting, which interferes with the ratcheting mechanism.The labeling lists the dry cycle time as 85 minutes.However, the hospital is reported to use a dry cycle time of only 50 minutes.This is inadequate to allow for the full drying of the device and leads to rust.A review of the dhr did not identify any issues which would have contributed to this event.

Event Description

It was reported that the ratcheting mechanism on a handle was found to be non-functional during a routine inspection.There were no surgical or patient impacts associated with this event.

• Brand Name: RATCHETING HANDLE - PALM
• Type of Device: WRENCH (RATCHETING HANDLES)
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7366370
• MDR Text Key: 103342780
• Report Number: 3012447612-2018-00304
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02105.001
• Device Lot Number: 63028563
• Other Device ID Number: (01)00889024010390(10)63028563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1